Job Description
Job Description
Job Description
Salary: DOE
INTERNATIONAL REGULATORY MANAGER
About the Role:
The International Regulatory Manager is a high-level contributor responsible for driving global regulatory strategy, performing in-depth country-specific research, conducting formulation and substantiation reviews, and supporting the successful market entry of products worldwide. This role will primarily focus on regulatory compliance across the APAC, LATAM, MENA, and EU regions and work closely with cross-functional teams, international partners, and regulatory bodies to ensure adherence to evolving international laws and guidelines. A primary function of this position is to prepare and manage international documents required for registration, import, and/or resale of Swanson Health Products outside of the United States. The role will also necessitate knowledge and understanding of product and ingredient restrictions, label requirements as dictated by the various in-country regulatory. This position is expected to manage risk assessments to support international business growth. International regulatory experience is required.
Essential Responsibilities:
- Have direct experience responding to documentation requests and how they differ in APAC, LATAM, or the EU.
- Have direct experience in acquiring, preparing and supplying requested documents necessary for country product registration, import and/or resale for our international distributors.
- Develop and manage a dynamic, region-specific library of frequently requested regulatory documents.
- Monitor country-specific ingredient, product, and import/export restrictions; promptly communicate updates to internal stakeholders.
- Have direct experience with country specific nutrient amounts and supplement food classifications for APAC, LATAM, or the EU.
- Have direct experience with claims made on products for different countries in the EU, APAC, or LATAM regions.
- Stay informed of country-specific labeling requirements in APAC, LATAM, or the EU.
- Stay informed of internet sale requirements in the EU, APAC, or LATAM countries we may choose to sell Swanson branded products.
- Review and address international customer product quality concerns and collaborate with appropriate personnel on formulating responses/remedies.
- Monitor regulatory and industry news websites and work with international partners to look for changes in the international regulatory environment, new legislation, enforcement actions, etc. Communicate findings to appropriate personnel and document on monthly update. Evaluate if changes/trends impact SHP and make recommendations to appropriate personnel.
- Work individually and with appropriate personnel to successfully complete assigned big picture projects and goals on, or before, due date.
- Provide support to functional departments by directly working with regulators on products that require regulatory submission, clearance, or approval from regulatory agencies such as: FDA, USDA, TGA, European Union Commission, China, Korea, and all other related agencies.
- Collaborate and work closely with the global team on regulatory changes, development and innovation strategies that create competitive advantage, and act as resource for the team on changing regulatory requirements and regulatory precedents in global markets.
- Review formulations during the product development cycle to ensure compliance and identify opportunities for additional market access.
- Conduct regulatory assessments of the current product portfolio to recommend global launch strategies.
- Support substantiation processes for product claims and health benefits, ensuring scientific backing aligns with country-specific requirements.
- Perform audits of marketing materials and distributor websites to ensure compliance with local laws and regulations.
- Develop and deliver training programs to internal teams on compliance obligations, industry best practices, and regulatory changes.
- Maintain a positive and professional working relationship with peers, management, and support resources, with a constant commitment to teamwork and exemplary customer service.
- Conducts self in the presence of customers and community so as to present a professional image of SHP.
- Ability to travel up to 25%
Competencies Required:
- Direct experience in international regulatory work, preferably in Dietary Supplements, Pet Care/Pet Food, Sports Nutrition, Flavors/Spices, or Conventional Food strongly preferred.
- Strong administrative skills
- Strong attention to detail
- Results-oriented, thriving in a challenging, fast-paced environment
- Ability to prioritize and effectively multi-task
- Ability to seek and find information from within the company and outside
- Ability to understand and interpret requests made by non-English speaking customers
- Ability to interpret regulatory guidelines and provide solutions
- Good communication skills
- Bilingual in either Spanish or Chinese a plus
- Working knowledge of library system, information services, and online research
- Nutritional supplement industry knowledge preferred
- Industry certifications (e.g., RAC) a plus.
Supervisory Responsibilities:
Manages subordinate; is responsible for the overall direction, coordination and evaluation of these units. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education & Experience:
- BA/BS or MS Degree in Science related field
- Experience with manufacturing, sale & functional food or dietary/nutritional supplements for domestic and international markets
- 7 or more years regulatory experience or; an equivalent combination of education & experience sufficient to successfully perform the essential responsibilities and duties of the job as listed above
Equipment & Software:
- Microsoft Office Suite
- General office equipment
- Adobe Acrobat Pro for PDF compilation and annotation of regulatory documents
- Regulatory Intelligence Tools (e.g., FoodChain ID, Chemlinked, or similar) for monitoring global regulations and compliance
- Document Management Systems (e.g., SharePoint, Veeva Vault, or similar) for version control and internal documentation library
- Collaboration tools (e.g., Teams, Zoom, Wrike, or Jira) for communication and project management
- Online Research Tools subscription databases, regulatory portals, WHO/FAO Codex, and national government sites
remote work
Job Tags
Local area, Remote job, Worldwide,